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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K151260
Device Name ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
Applicant
Cardiovascular System, Inc.
1228 Old Highway 8 NW
Saint Paul,  MN  55112
Applicant Contact Kim Wallner
Correspondent
Cardiovascular System, Inc.
1228 Old Highway 8 NW
Saint Paul,  MN  55112
Correspondent Contact Kim Wallner
Regulation Number870.4875
Classification Product Code
MCW  
Date Received05/12/2015
Decision Date 06/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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